Senior MES Engineer, CVRM (Holly Springs)
AI summary of the role
Senior MES Engineer for a greenfield drug product manufacturing site in Holly Springs, NC, focused on Rockwell PharmaSuite recipe authoring and system implementation.
No longer in the current catalog. Last included 2026-09-09. Check the employer’s posting for availability.
What you’ll do
- Lead design and implementation of Recipe Authoring (Master Recipes/Workflows) for drug product manufacturing in a GMP environment.
- Support MES system implementation including architecture components and interfaces to SAP, LIMS, and Automation.
- Act as MES lead for equipment/software FAT, SAT, field testing, and commissioning.
- Support plant operations by assessing discrepant events, troubleshooting automation issues, and providing real-time on-floor support.
What you’ll bring
- Minimum 5 years of applicable MES experience, preferably in drug product functions.
- Deep expertise with Rockwell PharmaSuite MES implementation and Recipe Authoring.
- Knowledge of biopharmaceutical manufacturing in a Greenfield/Facility Startup environment.
- Expert knowledge of GMP, 21 CFR Part 11, GAMP 5, and Data Integrity principles.
Technologies
Rockwell PharmaSuite · MES · SAP · LIMS · SQL · GAMP 5 · 21 CFR Part 11 · Data Historians · Automation
About Genentech
Biotechnology company discovering and developing medicines for serious and life-threatening diseases (oncology, neuroscience, immunology); operates as Roche's independent US pharma R&D and commercial arm.
Acquired · 5000+ people
Source and classification
Internal deployment & tooling · Evidence for this classification:
The Opportunity ITOT supports Pharma Technical Manufacturing (PTM). PTM is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From the raw material to the final medicine, we contribute to deliver Roche’s ground-breaking therapies to more than 120 million patients around the world. We make our medicines at 9 sites around the world and coordinate all aspects of production of Roche medicines in all disease areas and dosage forms. To ensure readiness for a step-change in the standard of care that Roche delivers in the area of Cardiovascular, Renal and Metabolism (CVRM), PTM will construct a new manufacturing site in the U.S. in Holly Springs, North Carolina. ITOT will own and operate Manufacturing Technology stack at the site working with Global IT. The new site will focus on large volume low cost Drug Product manufacturing
More from the job description
The Opportunity ITOT supports Pharma Technical Manufacturing (PTM). PTM is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From the raw material to the final medicine, we contribute to deliver Roche’s ground-breaking therapies to more than 120 million patients around the world. We make our medicines at 9 sites around the world and coordinate all aspects of production of Roche medicines in all disease areas and dosage forms. To ensure readiness for a step-change in the standard of care that Roche delivers in the area of Cardiovascular, Renal and Metabolism (CVRM), PTM will construct a new manufacturing site in the U.S. in Holly Springs, North Carolina. ITOT will own and operate Manufacturing Technology stack at the site working with Global IT. The new site will focus on large volume low cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products). The Sr MES Engineer is being hired to participate in Greenfield Project execution and subsequently support the facility after going live. Focus of the role is Pharmasuite recipe authoring with expectation to grow in MES beyond authoring. Initially, you will perform a mix of remote and onsite work (first at the General Planner’s office, later at the construction site/plant). You [... source excerpt omitted ...] ecute system administration, user access management, and application performance monitoring. 24/7 Readiness: Participate in a 24/7 on-call environment to meet business continuity requirements after the facility goes live. Knowledge, Skills, and Abilities PharmaSuite MES Expertise: Deep expertise with MES System implementation and Recipe Authoring, specifically in the Rockwell PharmaSuite platform. MES Lifecycle Support: Demonstrated experience in providing long-term operational support, including patch management, system upgrades, and configuration control. Technical Systems Aptitude: Ability to carry out or learn System Engineering responsibilities, including underlying databas [... source excerpt omitted ...] this role The expected salary range for this position based on the primary location of Holly Springs, NC is $78,900 - $146,500. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawfu
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